Multi-chamber intracardiac pacing system

ABSTRACT

A medical device system including at least a first implantable medical device and a second implantable medical device is configured to establish by a control module of the first implantable medical device whether the second implantable medical device is present in a patient and self-configure an operating mode of the control module in response to establishing that the second implantable medical device is present.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. Provisional PatentApplication No. 62/025,716, which was filed Jul. 17, 2014, and is herebyincorporated herein by reference in its entirety.

TECHNICAL FIELD

The disclosure relates to an implantable medical device system andassociated method for controlling the monitoring and therapy deliveryfunctions of an intracardiac pacing device.

BACKGROUND

Implantable cardiac pacemakers are commonly placed in a subcutaneouspocket and coupled to one or more transvenous medical electrical leadscarrying pacing and sensing electrodes positioned in the heart. Acardiac pacemaker implanted subcutaneously may be a single chamberpacemaker coupled to one medical lead for positioning electrodes in oneheart chamber, atrial or ventricular, or a dual chamber pacemakercoupled to two leads for positioning electrodes in both an atrial and aventricular chamber. Multi-chamber pacemakers are also available thatmay be coupled to three leads for positioning electrodes for pacing andsensing in one atrial chamber and both the right and left ventricles.

The pacing mode of a pacemaker is commonly designated by a three- orfour-letter code. The first letter may be an “A” for atrial, “V” forventricular or “D” for dual (atrial and ventricular) to indicate whichchamber(s) are paced. The second letter indicates which chamber(s) aresensed again designated by an “A,” “V,” or “D.” The third letterindicates how the pacemaker responds when it senses a cardiac event. Forexample, a sensed cardiac event may trigger a pacing pulse and isindicated by a letter “T” or a sensed cardiac event may inhibit a pacingpulse and is indicated by a letter “I.” In some cases, sensed cardiacevents may both trigger and inhibit a pacing pulse depending on whichchamber the event was sensed in. This dual response is indicated by thethird letter “D.”

By this convention, an AAI pacing mode delivers pacing pulses in anatrial chamber, senses atrial P-waves attendant to atrial depolarizationin the atrium, and inhibits the atrial pacing pulse when a P-wave issensed. A VVI pacing mode delivers pacing pulses in a ventricularchamber, senses ventricular R-waves attendant to ventriculardepolarization, and inhibits the ventricular pacing pulse when theR-wave is sensed.

One pacing mode is a DDD mode, which includes dual chamber pacing inboth an atrial and ventricular chamber, dual chamber sensing in both anatrial and ventricular chamber, and a dual response to sensed events.For example, a sensed P-wave may trigger a ventricular pacing pulse at aprogrammed atrioventricular (AV) interval (atrial-triggered ventricularpacing), but a sensed R-wave during the AV interval inhibits theventricular pacing pulse. Available dual chamber pacemakers that arecapable of performing DDD pacing are implanted in a subcutaneous pocketand coupled to a transvenous atrial lead and a transvenous ventricularlead carrying atrial pacing and sensing electrodes and ventricularpacing and sensing electrodes, respectively, to enable the dual chamberpacemaker to sense and pace in both chambers.

A fourth letter, R, may be used to designate a rate responsive pacingmode of the pacemaker. In rate responsive pacing, the pacing rate isautomatically adjusted in response to a sensor that indicates themetabolic need of the patient, such as a patient activity sensor. AnAAIR, VVIR, or DDDR pacing mode is configured to provide rate responsivepacing in the indicated heart chamber(s) by automatically adjusting thepacing lower rate according to a sensor signal indicating the patient'smetabolic need.

SUMMARY

In general, the disclosure is directed to implantable medical device(IMD) systems that include multiple implantable medical devices. Atleast one IMD has a self-configuring control module that enables the IMDto operate in a coordinated manner with another IMD that is implanted inthe same patient. An IMD operating in accordance with the techniquesdisclosed herein establishes the presence of one or more other IMDs andself-configures an appropriate operating mode in response toestablishing the presence of another IMD.

In one example, the disclosure provides an IMD system comprising a firstimplantable medical device; and a second implantable medical device. Thefirst implantable medical device includes a control module configured tocontrol operations of the first implantable medical device according toan operating mode of the first control module. The control module isconfigured to establish whether the second implantable medical device ispresent in a patient and self-configure the operating mode of thecontrol module in response to establishing that the second implantablemedical device is present.

In another example, the disclosure provides a method performed by animplantable medical device system. The method includes establishing by acontrol module of a first implantable medical device whether a secondimplantable medical device is present in a patient and self-configuringan operating mode of the control module in response to establishing thatthe second implantable medical device is present.

In yet another example, the disclosure provides a non-transitory,computer-readable storage medium storing a set of instructions that whenexecuted by a control module of a first implantable medical deviceincluded in an implantable medical device system cause the system toestablish whether a second implantable medical device is present in apatient and self-configure an operating mode of the control module inresponse to establishing that the second implantable medical device ispresent.

This summary is intended to provide an overview of the subject matterdescribed in this disclosure. It is not intended to provide an exclusiveor exhaustive explanation of the apparatus and methods described indetail within the accompanying drawings and description below. Furtherdetails of one or more examples are set forth in the accompanyingdrawings and the description below.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a conceptual diagram illustrating an intracardiac pacingsystem that may be used to sense cardiac electrical signals and providetherapy to a patient's heart.

FIG. 2A is a conceptual diagram of an intracardiac pacemaker.

FIGS. 2B and 2C are conceptual diagrams of alternative embodiments of anintracardiac pacemaker.

FIG. 3 is a functional block diagram of an example configuration of theintracardiac pacemaker shown in FIG. 2A, 2B or 2C.

FIG. 4 is a conceptual diagram of self-configuring operating modes of anintracardiac pacemaker.

FIG. 5 is a flow chart of the operation of an intracardiac atrialpacemaker and an intracardiac ventricular pacemaker both enabled toautomatically configure solo and duo operating modes according to thepresence or absence of the other pacemaker.

FIG. 6 is a functional block diagram of sensing and pacing controlmodules included in an intracardiac pacemaker according to one example.

FIG. 7 is a timing diagram depicting the operation of right atrial andright ventricular intracardiac pacemakers when configured in duooperating modes.

FIG. 8 is a flow chart of a method for controlling ventricular pacing byan intracardiac ventricular pacemaker.

FIG. 9 is a conceptual diagram of another example of an IMD systemincluding multiple, self-configuring intracardiac pacemakers and otherextracardiac implantable medical devices.

DETAILED DESCRIPTION

An implantable medical device (IMD) system is disclosed herein thatincludes self-configuring IMDs. In various examples, the IMD systemincludes self-configuring intracardiac pacemakers that do not requiretransvenous leads but are enabled to provide multi-chamber monitoringand/or therapy delivery functions, such as dual chamber DDD(R) pacing,in a coordinated manner via self-configuring operating modes.

An intracardiac pacemaker included in the system has a control modulethat self-configures the pacemaker operating mode in response toestablishing the presence of other IMDs implanted in the patient inorder to provide coordinated and efficient operation between theintracardiac pacemaker and one or more other implanted intracardiacpacemakers and/or other IMDs. When more than one intracardiac pacemakeris present, each pacemaker may self-configure its operating mode toenable multi-chamber sensing and/or therapy delivery functions to beachieved by the separate intracardiac pacemakers in a coordinatedmanner.

A dual chamber pacemaker positioned in an implant pocket and coupled totransvenous atrial and ventricular leads may be programmed in an AAI(R),VVI(R) or DDD(R) mode according to patient need. The dual chamberpacemaker is able to control the delivery of pacing pulses in bothatrial and ventricular chambers because the pacemaker will receivesensed event signals from both chambers and control when a pacing pulseis delivered in both chambers relative to sensed events using theelectrodes positioned in both chambers. In other words, the dual chamberpacemaker knows when both sensed and paced events have occurred in bothatrial and ventricular pacing channels since all sensing and pacingcontrol is happening in the one device, i.e., the dual chamberpacemaker.

Intracardiac pacemakers have been introduced that are adapted to beimplanted wholly within a heart chamber. Elimination of transvenous,intracardiac leads has several advantages. For example, complicationsdue to infection associated with a lead extending from a subcutaneouspacemaker pocket transvenously into the heart can be eliminated. Othercomplications such as “Twiddler's syndrome”, lead fracture or poorconnection of the lead to the pacemaker are eliminated in the use of anintracardiac pacemaker.

An intracardiac pacemaker can operate in a single chamber mode, e.g.,AAI or VVI, by delivering pacing pulses and inhibiting pacing when anintrinsic event is sensed in the chamber that the pacemaker is implantedin. While some patients may require only single chamber pacing andsensing, patients having AV conduction defects may require a pacingsystem capable of a DDD pacing mode to provide atrial-synchronizedventricular pacing. As disclosed herein, an IMD system includesintracardiac pacemakers that are configured to establish whether anotherIMD is present in the patient's body and self-configure its ownoperating mode from multiple self-configuring operating modes based onthe presence or absence of the other IMD(s). When two or moreintracardiac pacemakers are present, the ability to configure anoperating mode that coordinates the operation of one pacemaker with theoperation of the other pacemaker enables the two pacemakers to performmulti-chamber monitoring and therapy delivery operations, e.g., DDDpacing, in an effective and efficient manner.

FIG. 1 is a conceptual diagram illustrating an intracardiac pacingsystem 10 that may be used to sense cardiac electrical signals andprovide therapy to a patient's heart 8. IMD system 10 includes a rightatrial (RA) intracardiac pacemaker 12 and a right ventricular (RV)intracardiac pacemaker 14. Pacemakers 12 and 14 are shown astranscatheter intracardiac pacemakers adapted for implantation whollywithin a heart chamber, e.g., wholly within the RV, wholly within theleft ventricle (LV), wholly within the RA or wholly within the leftatrium (LA) of heart 8. In the example of FIG. 1, pacemaker 12 ispositioned along an endocardial wall of the RA, e.g., along the RAlateral wall or RA septum. Pacemaker 14 is positioned along anendocardial wall of the RV, e.g., near the RV apex. The techniquesdisclosed herein, however, are not limited to the pacemaker locationsshown in the example of FIG. 1 and other positions and relativelocations from each other are possible.

Pacemakers 12 and 14 are reduced in size and generally cylindrical inshape to enable transvenous implantation via a delivery catheter. Inother examples, pacemakers 12 and 14 may be positioned at any otherlocation inside or outside heart 8, including epicardial locations. Forexample, pacemaker 12 may be positioned outside or within the rightatrium or left atrium to provide respective right atrial or left atrialpacing. Pacemaker 14 may be positioned outside or within the rightventricle or left ventricle to provide respective right ventricular orleft ventricular pacing.

Pacemakers 12 and 14 are each capable of producing electricalstimulation pulses, i.e., pacing pulses, delivered to heart 8 via one ormore electrodes on the outer housing of the pacemaker. RA pacemaker 12is configured to sense an intracardiac electrogram (EGM) signal in theRA using the housing based electrodes and deliver RA pacing pulses. RVpacemaker 14 is configured to sense an EGM signal in the RV using one ormore housing based electrodes and deliver RV pacing pulses.

Depending on individual patient need, RA pacemaker 12 may be implantedfirst, and RV pacemaker 14 may be implanted at a later time after thepatient develops a need for ventricular pacing, e.g., if the patientdevelops AV conduction defects. In other examples, the patient mayreceive the RV pacemaker 14 first and later receive RA pacemaker 12, orthe patient may receive both RA pacemaker 12 and RV pacemaker 14 duringthe same implant procedure.

The RA pacemaker 12 and the RV pacemaker 14 are configured to detect thepresence (or absence) of the other pacemaker and automatically select asolo operating mode or a duo operating mode based on whether the otherpacemaker is present or not. Each of the RA pacemaker 12 and RVpacemaker 14 include a control module that controls functions performedby the respective pacemaker. The control module is enabled toself-configure the solo or duo operating mode in response to thepresence or absence of the other pacemaker.

As will be described in greater detail below, each pacemaker 12 and 14includes features and capabilities that are enabled or disabledautomatically when an operating mode is self-configured. In some cases,the operating mode is adjusted automatically by the pacemaker controlmodule based on the presence or absence of other types of implantedmedical devices, such as an implantable cardioverter defibrillator(ICD), implantable ECG monitor, or other cardiac monitoring or therapydelivery device.

Pacemaker 12 and 14 are each capable of bidirectional wirelesscommunication with an external device 20. External device 20 may be aprogrammer used by a clinician or other user in a medical facility, ahome monitor located in a patient's home, or a handheld device. Aspectsof external device 20 may generally correspond to the externalprogramming/monitoring unit disclosed in U.S. Pat. No. 5,507,782(Kieval, et al.), hereby incorporated herein by reference in itsentirety.

External device 20 establishes a wireless radio frequency (RF)communication link 22 with RA pacemaker 12 and wireless RF communicationlink 24 with RV pacemaker 14 using a communication protocol thatappropriately addresses the targeted pacemaker 12 and 14. An example RFtelemetry communication system that may be implemented in system 10 isgenerally disclosed in U.S. Pat. No. 5,683,432 (Goedeke, et al.),incorporated herein by reference in its entirety.

External device 20 may be used for retrieving data from pacemakers 12and 14 and for sending data to pacemakers 12 and 14. Examples ofretrieved data include physiological signals such as RA or RV EGMsignals, therapy delivery data such as a history of pacing frequency,results of device diagnostic testing, current operating mode and controlparameters or other data stored by the pacemaker.

Data sent to pacemakers 12 and 14 may include programmable controlparameters. The self-configuring control module may establish whichprogrammable control parameters and corresponding settings are availablefor a user to program based on the selected operating mode. Thepacemaker 12 or 14 may transmit operating mode data to external device20, e.g., in response to an interrogation command from external device20, such that external device 20 displays user programmable parametersand settings relevant to the operating mode.

Pacemaker 12 and pacemaker 14 may or may not be configured tocommunicate directly with each other. For example, neither RA pacemaker12 nor RV pacemaker 14 may be configured to initiate an RF communicationsession with the other device. Both pacemakers 12, 14 may be configuredto periodically “listen” for a valid “wake up” telemetry signal fromexternal device 20 and power up its own telemetry module to establish acommunication link 22 or 24 in response to a valid telemetry signal (orgo back to “sleep” if no valid telemetry signal is received). However,pacemakers 12 and 14 may not be configured to transmit a “wake up”signal to the other pacemaker to initiate a communication session. Inother examples, the pacemakers 12 and 14 may be configured tocommunicate with each other, but in order to conserve battery life ofthe intracardiac pacemakers, communication may be minimized. As such,communication may not occur on a beat-by-beat basis between the RApacemaker 12 and RV pacemaker 14 for communicating when the otherpacemaker is sensing cardiac events or when it is delivering pacingpulses.

A subcutaneously implanted dual chamber pacemaker is generally coupledto transvenous leads carrying electrodes positioned in both the RA andthe RV. When a pacemaker is coupled to electrodes positioned in bothchambers, P-wave sense signals and R-wave sense signals are available tocontrol both atrial and ventricular pacing pulses in a coordinatedmanner with the sensed events. In system 10 of FIG. 1, RA pacemaker 12and RV pacemaker 14 may not be enabled to communicate by wireless RFtelemetry on a beat-by-beat basis. The pacemaker in one heart chamber(RA or RV) does not receive communication signals transmitted directlyfrom the other pacemaker in the other heart chamber indicating when theother pacemaker has sensed a cardiac event or when it has delivered apacing pulse. In accordance with techniques disclosed herein, however,RV pacemaker 14 may be configured to sense far-field (FF) P-waves and FFatrial pacing pulses from the RV EGM signal. RV pacemaker 14 maytherefore be enabled to indirectly determine when RA pacemaker 12delivers a pacing pulse and/or when RA pacemaker 12 has most likelysensed a P-wave. Likewise, RA pacemaker 12 may be configured to sense FFventricular events, including R-waves and/or ventricular pacing pulses.

As will be described herein, in a duo operating mode, the two pacemakers12 and 14 may be configured to determine if a pacing pulse has beendelivered by the other pacemaker and/or when an evoked or intrinsicevent has been sensed by the other pacemaker such that the twoindividual pacemakers 12 and 14 can operate in a coherent, coordinatedmanner for delivering dual chamber pacing. In this way, a DDD(R) pacingmode is achieved by the operation of the two separate intracardiacpacemakers 12 and 14 without requiring direct communication, e.g., wiredsignals or wireless RF communication signals, between the two pacemakers12 and 14 on a beat-by-beat basis.

The control module of at least a first one of the two pacemakers 12 and14 is configured to determine when the second pacemaker is sensing anevent and/or delivering a pacing pulse based on sensed event signalsproduced by a sensing module of the first pacemaker. In addition tocoordinating dual chamber pacing, the self-configured operating modesets the status of other pacemaker functions as being enabled, disabledor otherwise adjusted based on the presence or absence of the otherpacemaker, or another implanted device.

FIG. 2A is a conceptual diagram of an intracardiac pacemaker 100 thatmay correspond to RA pacemaker 12 or RV pacemaker 14 shown in FIG. 1.Pacemaker 100 includes electrodes 162 and 164 spaced apart along thehousing 150 of pacemaker 100 for sensing cardiac EGM signals anddelivering pacing pulses. Electrode 164 is shown as a tip electrodeextending from a distal end 102 of pacemaker 100, and electrode 162 isshown as a ring electrode along a mid-portion of housing 150, forexample adjacent proximal end 104. Distal end 102 is referred to as“distal” in that it is expected to be the leading end as it advancedthrough a delivery tool such as a catheter and placed against a targetpacing site.

Electrodes 162 and 164 may be positioned on or as near as possible torespective proximal and distal ends 104 and 102 to increase theinter-electrode spacing between electrodes 162 and 164. Electrodes 162and 164 form an anode and cathode pair for bipolar cardiac pacing andsensing. Relatively greater inter-electrode spacing will increase thelikelihood of sensing FF signals that are used by the pacemaker 100 fordetecting the presence of another pacemaker in another heart chamberand/or in coordinating pacing pulse delivery with a paced or sensedevent in another heart chamber. For example, an increasedinter-electrode spacing between electrodes 162 and 164 when pacemaker100 is used as an RV pacemaker will improve the likelihood of reliablysensing FF P-waves.

In alternative embodiments, pacemaker 100 may include two or more ringelectrodes, two tip electrodes, and/or other types of electrodes exposedalong pacemaker housing 150 for delivering electrical stimulation toheart 8 and sensing EGM signals. Electrodes 162 and 164 may be, withoutlimitation, titanium, platinum, iridium or alloys thereof and mayinclude a low polarizing coating, such as titanium nitride, iridiumoxide, ruthenium oxide, platinum black among others. Electrodes 162 and164 may be positioned at locations along pacemaker 100 other than thelocations shown.

Housing 150 is formed from a biocompatible material, such as a stainlesssteel or titanium alloy. In some examples, the housing 150 may includean insulating coating. Examples of insulating coatings include parylene,urethane, PEEK, or polyimide among others. The entirety of the housing150 may be insulated, but only electrodes 162 and 164 uninsulated. Inother examples, the entirety of the housing 150 may function as anelectrode instead of providing a localized electrode such as electrode162.

The housing 150 includes a control electronics subassembly 152, whichhouses the electronics for sensing cardiac signals, producing pacingpulses and controlling therapy delivery and other functions of pacemaker100. Housing 150 further includes a battery subassembly 160, whichprovides power to the control electronics subassembly 152. Batterysubassembly 160 may include features of the batteries disclosed incommonly-assigned U.S. Pat. No. 8,433,409 (Johnson, et al.) and U.S.Pat. No. 8,541,131 (Lund, et al.), both of which are hereby incorporatedby reference herein in their entirety.

Pacemaker 100 may include a set of fixation tines 166 to securepacemaker 100 to patient tissue, e.g., by interacting with theventricular trabeculae. Fixation tines 166 are configured to anchorpacemaker 100 to position electrode 164 in operative proximity to atargeted tissue for delivering therapeutic electrical stimulationpulses. Numerous types of active and/or passive fixation members may beemployed for anchoring or stabilizing pacemaker 100 in an implantposition. Pacemaker 100 may include a set of active fixation tines asdisclosed in commonly-assigned, pre-grant publication U.S. 2012/0172892(Grubac, et al.), hereby incorporated herein by reference in itsentirety.

Pacemaker 100 may further include a delivery tool interface 158.Delivery tool interface 158 is located at the proximal end 104 ofpacemaker 100 and is configured to connect to a delivery device, such asa catheter, used to position pacemaker 100 at an implant location duringan implantation procedure, for example within a heart chamber.

A reduced size of pacemaker 100 enables implantation wholly within aheart chamber. In FIG. 1, RA pacemaker 12 and RV pacemaker 14 may havedifferent dimensions. For example, RA pacemaker 12 may be smaller involume than pacemaker 14, e.g., by reducing battery size, to accommodateimplantation in the smaller heart chamber. As such, it is recognizedthat pacemaker 100 may be adapted in size, shape, electrode location orother physical characteristics according to the heart chamber in whichit will be implanted.

FIG. 2B is a conceptual diagram of an alternative embodiment of anintracardiac pacemaker 110. Pacemaker 110 includes a housing 150,control assembly 152, battery assembly 160, fixation member 166 andelectrode 164 along a distal end 102, and may include a delivery toolinterface 158 along the proximal end 104 as described above inconjunction with FIG. 2A. Pacemaker 110 is shown to include an electrode162′ extending away from housing 150 along an extender 165. As such,instead of carrying a pair of electrodes along the housing 150, whichlimits the maximum possible inter-electrode spacing, an extender 165 maybe coupled to the housing 150 for positioning an electrode 162′ at anincreased inter-electrode distance from distal tip electrode 164.Reference is made to U.S. Patent Application No. 62/025,690, filedprovisionally on Jul. 17, 2014, incorporated herein by reference in itsentirety, for examples of an intracardiac pacemaker having increasedinter-electrode spacing between electrodes.

FIG. 2C is a conceptual diagram of an alternative embodiment ofintracardiac pacemaker 120 having extender 165 coupled to the distal end102 of pacemaker housing 150 to extend distal electrode 164′ away fromelectrode 162 positioned along housing 150 near or at proximal end 104.Extender 165 shown in FIGS. 2B and 2C is an insulated electricalconductor that electrically couples electrode 162′ (FIG. 2B) orelectrode 164′ (FIG. 2C) to pacemaker circuitry. Pacemaker 120 having aninsulated, electrically conductive extender 165 for increasing theinter-electrode spacing may correspond generally to the implantabledevice and flexible conductor disclosed in commonly-assigned, pre-grantU.S. Publication No. 2013/0035748 (Bonner, et al.), hereby incorporatedherein by reference in its entirety.

FIG. 3 is a functional block diagram of an example configuration ofpacemaker 100 shown in FIG. 2A (or pacemakers 110 or 120 of FIGS. 2B and2C), and may correspond generally to the functional circuitry includedin both RA pacemaker 12 and RV pacemaker 14. Pacemaker 100 includes apulse generator 202, a sensing module 204, a control module 206, memory210, telemetry module 208 and a power source 214.

As used herein, the term “module” refers to an application specificintegrated circuit (ASIC), an electronic circuit, a processor (shared,dedicated, or group) and memory that execute one or more software orfirmware programs, a combinational logic circuit, or other suitablecomponents that provide the described functionality. The particular formof software, hardware and/or firmware employed to implement thefunctionality disclosed herein will be determined primarily by theparticular system architecture employed in the pacemaker. Providingsoftware, hardware, and/or firmware to accomplish the describedfunctionality in the context of any modern IMD, given the disclosureherein, is within the abilities of one of skill in the art.

Each of RA pacemaker 12 and RV pacemaker 14 may include similar modulesas represented by the pacemaker 100 shown in FIG. 3; however it isunderstood that the modules may be configured according to thefunctionality of the separate RA and RV pacemakers 12 and 14 asdisclosed herein. For example, when pacemaker 100 is a RA pacemaker 12,control module 206 is enabled to self-configure the solo and duooperating modes of the RA pacemaker as disclosed herein. Likewise, whenpacemaker 100 is a RV pacemaker 14, control module 206 is enabled toself-configure the solo and duo operating modes of the RV pacemaker asdisclosed herein. Adaptations of the hardware, firmware or software ofthe various modules necessary to meet the described functionality of theintracardiac pacemakers positioned in different heart chambers asdisclosed herein is understood to be included in the various modules.

The functions attributed to pacemaker 100 herein may be embodied as oneor more processors, controllers, hardware, firmware, software, or anycombination thereof. Depiction of different features as specificcircuitry or modules is intended to highlight different functionalaspects and does not necessarily imply that such functions must berealized by separate hardware or software components or by anyparticular architecture. Rather, functionality associated with one ormore modules, processors, or circuits may be performed by separatehardware or software components, or integrated within common hardware orsoftware components. For example, pacing control operations performed bypacemaker 100 may be implemented in control module 206 executinginstructions stored in associated memory 210 and relying on input fromsensing module 204.

Pulse generator 202 generates electrical stimulation pulses that aredelivered to heart tissue via electrodes 162 and 164. Electrodes 162 and164 may be housing-based electrodes as shown in FIG. 2A, but one or bothelectrodes 162 and 164 may alternatively be carried by an insulated,electrical conductor extending away from the pacemaker housing asdescribed in conjunction with FIGS. 2B and 2C.

Pulse generator 202 may include one or more capacitors and a chargingcircuit to charge the capacitor(s) to a programmed pacing pulse voltage.At appropriate times, as controlled by a pace timing and control circuitincluded in control module 206, the capacitor is coupled to pacingelectrodes 162 and 164 to discharge the capacitor voltage and therebydeliver the pacing pulse. Pacing circuitry generally disclosed in theabove-incorporated U.S. Pat. No. 5,597,782 (Kieval, et al.) and incommonly assigned U.S. Pat. No. 8,532,785 (Crutchfield, et al.),incorporated herein by reference in its entirety, may be implemented inpacemaker 100 for charging a pacing capacitor to a predetermined pacingpulse amplitude under the control of control module 206 and delivering apacing pulse.

Control module 206 controls pulse generator 202 to deliver a pacingpulse in response to expiration of a pacing timing interval according toprogrammed therapy control parameters stored in memory 210. Controlmodule 206 self-configures an operating mode based on establishingwhether another pacemaker is present or not. Within a given operatingmode, one or more pacing modes may be available, each defined by anappropriate set of control parameters. The pace timing and controlcircuit included in control module 206 sets various timing intervals,often referred to as escape intervals, used for controlling the timingof pacing pulses relative to a paced or sensed event. Upon expiration ofa pacing timing interval, a pacing pulse is delivered. If a cardiacevent is sensed during the pacing timing interval, the scheduled pacingpulse may be inhibited, and the pacing timing interval may be restarted.

For example, RA pacemaker 12 (FIG. 1) may operate by starting a lowerrate pacing escape interval in response to an intrinsic sensed P-wave oran atrial pacing pulse. If the escape interval expires prior to sensinga next intrinsic P-wave, an atrial pacing pulse is delivered. If anintrinsic P-wave is sensed by sensing module 204, the escape interval isrestarted. Similarly, RV pacemaker 14 (FIG. 1) may set a lower ratepacing escape interval in response to an intrinsic sensed R-wave orventricular pacing pulse. If the escape interval expires, a ventricularpacing pulse is delivered by pulse generator 202. If an R-wave is sensedduring the escape interval, outside any applicable blanking orrefractory intervals, the escape interval is restarted.

Sensing module 204 includes cardiac event detectors for receivingcardiac EGM signals developed across electrodes 162 and 164. A cardiacevent is sensed by sensing module 204 when the EGM signal crosses asensing threshold, which may be an auto-adjusting sensing threshold, ofa cardiac event detector. In response to a sensing threshold crossing,sensing module 204 passes a sensed event signal to control module 206.RA pacemaker 12 may be programmed with a sensing threshold appropriatefor sensing P-waves attendant to the depolarization of the atria. RVpacemaker 14 may be programmed with a sensing threshold appropriate forsensing R-waves attendant to the depolarization of the ventricles.

The terms “sensed cardiac events” or “sensed events” as used hereinrefers to events sensed by sensing module 204 in response to the EGMsignal crossing a sensing threshold, which may be an amplitudethreshold, a frequency threshold, a slew rate threshold, or anycombination thereof. Sensed cardiac events may include intrinsic eventsand evoked events, both of which may also be referred to as“depolarization events” since both intrinsic and evoked sensed cardiacevents are associated with depolarization of the myocardium, either anintrinsic depolarization or a pacing evoked depolarization of themyocardium, respectively. Intrinsic events are events arising in theheart in the absence of a pacing pulse. Intrinsic events includeintrinsic P-waves, such as sinus P-waves originating from thesino-atrial node of the heart, and intrinsic R-waves, such as sinusR-waves conducted from the atria via the atrioventricular node.Intrinsic events can also include non-sinus intrinsic events, such aspremature atrial contractions (PACs) or premature ventricularcontractions (PVCs) that arise intrinsically from the heart but areectopic in origin.

Sensed intrinsic events may include near-field (NF) events and far-field(FF) events. NF events are events that are occurring in the heartchamber where the bipolar sensing electrodes 162 and 164 are positioned.FF events are events occurring in a different heart chamber, whereelectrodes 162 and 164 are not positioned. As described herein,pacemaker 100 may sense NF and FF events for monitoring the patient'sheart and/or for controlling pacing pulse delivery. As such, sensingmodule 204 may include a NF sensing channel 222 for sensing NF eventsand providing NF sensed event signals to control module 206 and a FFsensing channel 224 for sensing FF events and providing FF sensed eventsignals to control module 206.

For example, the RA pacemaker 12 may sense both NF P-waves and FFR-waves. A P-wave sensing threshold may be used by NF sensing channel222, and a different R-wave sensing threshold may be used by FF sensingchannel 224 and applied to the same EGM signal received by electrodes162 and 164 to distinctly sense NF P-waves and FF R-waves. The thresholdmay be applied to a signal amplitude or other waveform morphologyfeatures to differentiate NF and FF signals. Additionally oralternatively, different sensing windows, refractory windows, and/orblanking intervals may be applied by control module 206 to discriminatebetween NF P-waves and FF R-waves based on timing. For example, arefractory or blanking interval may be set by the RA pacemaker controlmodule 206 following a P-wave sensed event signal or an atrial pacingpulse so that any event sensed during the refractory or blankinginterval may be identified as a FF R-wave and is not used to reset alower rate pacing escape interval and therefore ignored for determiningthe atrial intrinsic rate and for controlling atrial pacing.Alternatively, a sensed FF R-wave could also be used to set an escapeinterval for controlling the timing of the next atrial pacing pulse. Thesensed FF R-wave may be used by the RA pacemaker for monitoringpurposes, such as monitoring the AV conduction time between the atriaand the ventricles.

Far-field P-waves may be present on the ventricular EGM signal sensed byRV pacemaker 14. FF P-waves are typically much smaller in amplitude thanNF R-waves and are therefore distinguishable from R-waves based onamplitude. An R-wave sensing threshold can be set greater than anexpected FF P-wave amplitude so that R-waves are sensed when the EGMsignal received by electrodes 162 and 164 crosses the R-wave sensingthreshold in NF sensing channel 22. FF P-waves may be sensed by FFsensing channel 224 of the RV pacemaker using a different sensingthreshold than the NF R-wave sensing threshold, and optionally using adesignated P-wave sensing window applied by control module 206. FFP-wave sense signals received from FF sensing channel 224 may be used bycontrol module 206 to deliver atrial-synchronized ventricular pacing asfurther described below and as generally disclosed in theabove-incorporated U.S. Patent Application No. 62/025,690, filedprovisionally on Jul. 17, 2014.

As indicated above, events sensed by sensing module 204 may includeevoked events. An evoked event is the signal attendant to depolarizationof the myocardial tissue caused by a pacing pulse. Evoked events may besensed in order to verify capture of a pacing pulse. For example, the RApacemaker 12 may be configured to deliver a RA pacing pulse, set ablanking interval during the pacing pulse to prevent saturation of thesensing module 202 due to the pacing pulse, then set a capture detectionwindow. A P-wave sensed during the capture detection window is sensed asan evoked P-wave and is evidence that the pacing pulse successfullycaptured the atrium. The RA pacemaker 12 may sense both intrinsicP-waves and evoked P-waves. FF evoked R-waves caused by delivering of aventricular pacing pulse by RV pacemaker 14 may also be sensed by FFsensing channel 224. FF evoked P-waves caused by an atrial pacing pulsedelivered by RA pacemaker 12 may be sensed by the FF sensing channel 224in RV pacemaker 14.

Sensed events may further include sensing of a pacing pulse delivered byan intracardiac pacemaker in another heart chamber. For example, RApacing pulses delivered by RA pacemaker 12 may have a relatively highamplitude on the ventricular EGM signal received by the sensing module204 of RV pacemaker 14. Similarly, a RV pacing pulse delivered by RVpacemaker 14 may appear as a FF signal on the RA EGM signal received byRA pacemaker 12. Sensing module 204 may be configured to produce FFpacing pulse sense signals that are passed to control module 206 so thatone pacemaker can identify the time that the other pacemaker in anotherheart chamber has delivered a pacing pulse.

For example, in RV pacemaker 14, FF sensing channel 224 of sensingmodule 204 may be configured to sense FF atrial pacing pulses. Asdescribed in greater detail below, FF atrial pacing pulse sense signalsprovided to control module 206 are used to control the timing ofventricular pacing pulses during atrial-synchronized ventricular pacing.Depending on the frequency characteristics of the sensing module 204 andthe relative orientation of the pacemakers 12 and 14, and theirrespective electrodes, the RA pacing pulse may or may not be sensed bythe RV sensing module 204.

Sensing module 204 may include multiple sensing channels forintentionally sensing both NF and FF events, including NF and FFintrinsic events, NF and FF evoked events, and FF pacing pulse events.By intentionally sensing FF events, control module 206 can controlpacemaker 100 to operate in a coordinated manner with a pacemaker inanother heart chamber.

For example, RV pacemaker 14 may include a NF channel 222 for sensing NFR-waves and a FF channel 224 for sensing FF atrial pacing pulsesdelivered by RA pacemaker 12 and/or FF P-waves. The NF and FF sensingchannels 222 and 224 may have different band pass frequencies anddifferent sensing thresholds. FF sensing channel 224 may include one ormore cardiac event detectors or “sub-channels” to separately sensedifferent FF events, e.g., FF P-waves and FF atrial pacing pulses. Thesame EGM signal acquired across electrodes 162 and 164 is applied to allsensing channels, but different events are sensed based on the differentbandpass frequencies and sensing thresholds selected to enhance sensingof a desired NF or FF event.

In response to a sensing threshold crossing, sensing module 204 passessensed event signals to control module 206. Sensed event signals mayinclude FF pacing pulse sensed event signals, FF R-wave or P-wave sensedevent signals (e.g., FF P-waves in the case of RV pacemaker 14 and FFR-waves in the case of RA pacemaker 12), and NF R-wave or P-wave sensedevent signals (NF R-waves in the case of RV pacemaker 14 and NF P-wavesin the case of RA pacemaker 12).

Control module 206 uses the sensed event signals to control pulsegenerator 202 in a desired pacing mode as described in greater detailbelow. Additionally or alternatively, FF pacing pulse sensed eventsignals may be used by control module 206 to establish the presence ofan intracardiac pacemaker in another heart chamber.

Memory 210 may include computer-readable instructions that, whenexecuted by control module 206, cause control module 206 to performvarious functions attributed throughout this disclosure to pacemaker100. The computer-readable instructions may be encoded within memory210. Memory 210 may include any non-transitory, computer-readablestorage media including any volatile, non-volatile, magnetic, optical,or electrical media, such as a random access memory (RAM), read-onlymemory (ROM), non-volatile RAM (NVRAM), electrically-erasableprogrammable ROM (EEPROM), flash memory, or other digital media with thesole exception being a transitory propagating signal. Memory 210 storestiming intervals, counters, or other data used by control module 206 tocontrol the delivery of pacing pulses by pulse generator 202 accordingto the currently configured operating mode.

Pacemaker 100 may further include an accelerometer 212 for producing apatient activity signal passed to control module 206. Accelerometer 212may be embodied as a piezoelectric crystal for producing a signalcorrelated to body motion. The use of an accelerometer in anintracardiac device for obtaining a patient activity signal is generallydisclosed in U.S. patent application Ser. No. 14/174,514 filed on Feb.6, 2014 (Nikolski, et al.), hereby incorporated herein by reference inits entirety.

The accelerometer signal is used to determine a sensor-indicated rate(SIR) used to set a pacing escape interval for controlling the pacingrate to meet the metabolic demand of the patient. The atrial pacingescape interval or the ventricular pacing escape interval during singlechamber pacing modes is initially set according to a programmed lower orbase pacing rate to provide bradycardia pacing. The lower or base pacingrate may be automatically adjusted to provide rate responsive pacingbased on a sensor signal indicative of the patient's metabolic demand,such as a signal from accelerometer 212. The use of a patient activitysignal for providing rate-responsive pacing is generally disclosed inU.S. Pat. No. 7,031,772 (Condie, et al.), incorporated herein byreference in its entirety.

The signal produced by accelerometer 212 may additionally oralternatively be used by control module 206 to detect motion of anotherheart chamber for monitoring purposes. For example, when pacemaker 100is positioned in the RA as the RA pacemaker 12 in FIG. 1, a motionartifact on the accelerometer signal due to ventricular contraction atthe onset of the ventricular systolic ejection phase, may be identifiedas a surrogate for sensing FF R-waves as evidence of ventriculardepolarization. A time interval between an atrial event, paced orsensed, and the surrogate ventricular depolarization signal identifiedfrom the accelerometer signal may be measured as an AV conduction timeand used for AV conduction time monitoring by the RA pacemaker 12. Asdescribed below, AV conduction time monitoring by RA pacemaker 12 may beenabled during a solo operating mode to determine a need for RVpacemaker 14 based on increased AV conduction time.

Power source 214 provides power to each of the other modules andcomponents of pacemaker 100 as required. Control module 206 may executepower control operations to control when various components or modulesare powered to perform various pacemaker functions. Power source 214 mayinclude one or more energy storage devices, such as one or morerechargeable or non-rechargeable batteries. The connections betweenpower source 214 and other pacemaker modules and components are notshown in FIG. 3 for the sake of clarity.

Telemetry module 208 includes a transceiver and associated antenna fortransferring and receiving data via a radio frequency (RF) communicationlink. RF communication with external device 20 (FIG. 1), may occur inthe Medical Implant Communication Service (MICS) band, the Medical DataService (MEDS) band, or other frequency bands, including, but notlimited to a 2.4 GHz industrial, scientific and medical (ISM) band forBluetooth and IEEE 802.11 b/g/n standards. Telemetry module 208 may becapable of bi-directional communication with external device 20 over awide range of distances, e.g., up to approximately 10 meters. In otherexamples, telemetry communication may require the use of a programminghead placed in proximity of pacemaker 100 to facilitate data transfer.

FIG. 4 is a conceptual diagram 300 of the self-configuring operatingmodes of an intracardiac pacemaker 100 included in an IMD system, suchas system 10 of FIG. 1. The IMD system 10 includes at least oneintracardiac pacemaker 100 and may include two or more intracardiacpacemakers, e.g. RA pacemaker 12 and RV pacemaker 14 and an LVpacemaker. Each pacemaker may be implantable wholly within a heartchamber and therefore capable of delivering cardiac pacing in a singlechamber using an electrode bipole, e.g., electrodes 162 and 164. In someexamples, the IMD system includes at least one intracardiac pacemakerand may include one or more other cardiac monitoring or therapy deliverydevices such as an ICD or subcutaneous ECG monitor.

A first intracardiac pacemaker 100 is implanted and self-configures in asolo operating mode as indicated by state 302. The first intracardiacpacemaker operating in a solo mode establishes whether a secondintracardiac pacemaker is present. The presence of a second intracardiacpacemaker may be established based on a signal received from an externaldevice 20 notifying the first pacemaker that the second pacemaker hasbeen implanted. Alternatively, the presence of a second intracardiacpacemaker may be established based on sensing FF pacing pulse signals bythe sensing module 204 of the first pacemaker 100.

If a second pacemaker is detected as indicated by transition 304, thefirst pacemaker reconfigures itself (or self-configures) to a duooperating mode in state 306. The second pacemaker likewise establishesthe presence of the first pacemaker and self-configures in a duooperating mode in state 306. The second pacemaker being implanted mayreceive a notification signal from the external device 20 indicating thepresence of the first pacemaker. The second pacemaker automaticallyconfigures itself in the duo operating mode in state 306 in response tothe command. Alternatively, the second pacemaker, upon being implanted,may sense FF pacing pulses being delivered by the first pacemaker fromthe EGM signal received by the second pacemaker and automaticallyconfigure itself in the duo operating mode 306.

In one example, the first device implanted is the RA pacemaker 12 andthe second device implanted is the RV pacemaker 14. In another example,the first device is the RV pacemaker 14 and the second device is the RApacemaker 12. In yet another example the first device implanted iseither a RA pacemaker or a LV pacemaker and the second device is theother of the RA pacemaker and the LV pacemaker.

The time between implanting the first pacemaker and the second pacemakermay vary between patients. In some cases both pacemakers may beimplanted in the same procedure such that both devices self-configure inthe duo operating mode immediately or soon after implantation. In otherexamples, implantation of the second pacemaker may occur days, weeks,months or even years after the first pacemaker.

In some examples a third intracardiac pacemaker may be detected by thefirst and second pacemakers, as indicated by transition 308. The firstand second pacemakers may automatically switch from a duo mode to a triomode in state 310. Likewise, the third intracardiac pacemaker willself-configure in the trio mode 310 based on detection of the first andsecond pacemakers, automatically in response to FF sensed pacing pulsesor in response to a notification received from an external device. Inone example, a trio mode enables an intracardiac pacemaker 100 to senseFF events in one or two other heart chambers and use the FF events tomonitor the patient's heart rhythm and/or trigger or inhibit pacingpulses delivered in the heart chamber that the pacemaker 100 isimplanted in, based on the FF events.

In some cases, another device that is not an intracardiac pacemaker mayalready be present or implanted after an intracardiac pacemaker. Ifanother IMD other than an intracardiac pacemaker 100 is present, theintracardiac pacemaker 100 may modify its self-configured solo, duo, ortrio mode to operate in a manner that is desired when the other IMD ispresent. As such, the solo, duo and trio operating modes may refer tooperating modes that enable one, two or three intracardiac pacemakers tooperate appropriately alone or cooperatively with one or more otherintracardiac pacemakers. Each of the solo, duo and trio operating modesmay be modified based on the presence of another implantable deviceother than an intracardiac pacemaker. For example, a modified solo, duoor trio operating mode may disable an intracardiac pacemaker function toeliminate redundant functions that can be performed by another IMD andthereby conserve battery energy of the intracardiac pacemaker.

In other examples, a modified solo, duo or trio operating mode ofintracardiac pacemaker 100 may enable a feature or function available inthe pacemaker that is not used unless another IMD is present. Toillustrate, an intracardiac pacemaker 100 operating in solo mode oroperating in a duo mode when another intracardiac pacemaker is presentmay modify its solo or duo mode when an ICD is implanted includeanti-tachycardia pacing (ATP) delivery. ATP delivery by an IMD systemmay be undesired unless defibrillation capabilities are available. Whenan ICD is added to the IMD system, any intracardiac pacemakers presentmay modify their current operating mode to include ATP.

Implantable devices may be added or removed from the IMD system presentin a patient. As such, if three intracardiac pacemakers are present andoperating in the trio mode 310, one pacemaker may be removed or disabledas indicated by transition 312. In some cases, an implanted pacemakermay not be physically removed from the patient but may reach batteryend-of-life or be “turned off” such that it is no longer functional inthe implanted IMD system or is no longer delivering pacing therapy. Theremaining two devices will detect the removal of the second device fromthe system, either automatically based on sensed EGM signals or byreceiving a notification from an external device. The remainingpacemakers will self-configure in the duo operating mode in state 306.If another pacemaker is removed from the system as indicated bytransition 314, the remaining pacemaker detects the removal andself-configures itself in the solo operating mode in state 302.

The solo mode in state 302, duo mode in state 306, trio mode in state310 and so on for each intracardiac pacemaker present in an IMD systemmay be uniquely defined for the given pacemaker and for a givencombination of pacemakers. For example, if the RA pacemaker 12 ispresent initially and operating in the solo mode in state 302, it mayself-configure to a duo operating mode including one set of features andcontrol parameters in response to detecting the presence of a secondpacemaker, such as RV pacemaker 14 but switch to a different duo mode ofoperation including a different set of features and control parametersin response to detecting the presence of a different pacemaker such as aLA pacemaker. As such, for each intracardiac pacemaker that may beintroduced to the overall IMD system a unique solo mode of operation maybe defined in addition to one or more duo operating modes each definedaccording to the type and/or location of the second pacemaker that isimplanted, one or more trio modes each defined according to the type andlocation of the third pacemaker that is implanted, and so on.

While the presence of up to three implantable pacemakers is depicted inFIG. 4, the methods disclosed herein may be extended to fourintracardiac pacemakers operating in each of the four heart chambers, inwhich case a quad mode may be defined for each pacemaker. Eachintracardiac pacemaker may further include self-configured, modifiedoperating modes used when other types of IMDs are present, such as amodified solo operating mode with an ICD present, modified duo operatingmode with an ICD present, etc.

FIG. 5 is a flow chart 400 of the operation of an intracardiac atrialpacemaker 12 and an intracardiac ventricular pacemaker 14 both enabledto automatically configure respective solo and duo operating modesaccording to the presence or absence of the other pacemaker. In oneillustrative example, an intracardiac atrial pacemaker, such as RApacemaker 12, is implanted first at block 402. Many patients may requirebradycardia atrial pacing without requiring ventricular pacing due tonormal atrioventricular conduction. The atrial pacemaker is initiallyconfigured in the solo mode as indicated at block 404.

The atrial pacemaker 12 may be provided by the manufacturer in the solooperating mode by default or may self-configure in the solo mode inresponse to a notification from a programmer (or other external device)indicating the atrial pacemaker is the sole pacemaker, i.e., no otherintracardiac pacemakers are previously or simultaneously implanted. Thesolo operating mode may be defined by a combination of pacemakerfeatures and control parameters that control both monitoring functionsof the atrial pacemaker and therapy delivery functions of the atrialpacemaker.

For example, in a solo operating mode, the atrial pacemaker 12 may beconfigured to operate as single chamber atrial pacemaker deliveringbradycardia pacing in an AAI or AAIR pacing mode. As used herein, the“operating mode” refers to the overall functions of the pacemaker whichmay include physiological signal monitoring, bradycardia pacing, one ormore other types of cardiac stimulation therapy delivery such as ATP orcardiac resynchronization therapy (CRT), self-diagnostic testing andother device functions. As such, the bradycardia pacing mode designatedby the three or four letter sequence indicating which chamberbradycardia pacing is delivered in and which chamber(s) cardiac eventsare sensed in for use in controlling the timing of the bradycardiapacing pulses is one aspect of the overall operating mode. One or moreprogrammable pacing modes may be available within a given solo or duooperating mode.

In a solo operating mode configured at block 404, AV conduction blockmonitoring is turned on in one example. AV conduction block monitoringis turned on by enabling the atrial intracardiac pacemaker to sense FFR-waves for measuring time intervals between NF P-wave sensed eventsignals and FF R-wave sensed event signals received by the controlmodule from the sensing module. An absence or latency of FF R-waves isan indication of the development of AV block and may indicate a need foran intracardiac ventricular pacemaker. AV block monitoring may thereforebe enabled, i.e., turned “on”, in the solo mode at block 404. Datarelating to evidence of AV block based on FF R-wave sensing may bestored by the atrial pacemaker and transmitted to the external device (aprogrammer, home monitor, or other external device 20 as shown inFIG. 1) to alert a clinician or other user to the possible need forventricular pacing.

The solo operating mode configured at block 404 further includes anatrial (A) bradycardia pacing mode, e.g., AAI or AAIR mode. In someexamples, no other therapies are enabled in the solo operating modebesides single chamber pacing. Even though the atrial pacemaker may beconfigured for sensing FF R-waves in the solo operating mode, the pacingmode is designated as the AAI(R) mode since only NF P-waves inhibit ascheduled atrial pacing pulse and only NF P-waves or atrial pacingpulses (but not FF R-waves) are used to start atrial pacing escapeintervals. The atrial pacemaker is configured for dual chamber sensingin the solo operating mode since FF R-waves may be sensed by thepacemaker even though the atrial pacemaker does not receive EGM signalsfrom electrodes positioned in the ventricle. This “pseudo” dual chambersensing of both NF P-waves and FF R-waves may not be used in the timingand control of atrial pacing pulses, however, and the solo pacing modeis therefore referred to as AAI(R).

The solo operating mode of the atrial pacemaker may additionally includeFF ventricular pacing pulse monitoring (FF V PACE MONITORING ON). A FFsensing channel of the RA pacemaker may be enabled to sense FFventricular pacing pulses to detect the presence of an intracardiacventricular pacemaker.

At block 408, a ventricular pacemaker, such as RV pacemaker 14, may bedetected. Detection of a ventricular pacemaker by the atrial pacemakermay be based on a received telemetry signal from an external device.Alternatively or additionally, the solo operating mode of the atrialpacemaker may include automatic detection of ventricular pacemaker basedon FF ventricular pacing pulse monitoring enabled during the solooperating mode (block 404). If FF ventricular pacing pulses are sensed,detection of a ventricular pacemaker may be confirmed at block 408 basedupon ventricular pacemaker detection criteria, e.g., a minimum requirednumber of FF ventricular pacing pulse sensed events within apredetermined interval of time or predetermined number of atrial cardiaccycles (PP intervals). If no ventricular pacing pulses are sensed or theventricular pacemaker detection criteria are not satisfied, and/or nonotification signal is received from an external device, the atrialpacemaker remains in the solo mode (block 404).

A ventricular pacemaker, such as RV pacemaker 14 may be implanted, asindicated at block 420, at any time prior to, concomitantly with, orsubsequently to the atrial pacemaker implantation. If RV pacemaker 14 isdetected by RA pacemaker 12 at block 408, RA pacemaker 12 automaticallyconfigures itself in a duo operating mode at block 410. The atrialpacemaker duo operating mode may include adjustments to monitoringfunctions and/or therapy delivery functions.

For example, since a ventricular pacemaker is now present, AV blockmonitoring that was enabled during the solo operating mode for thepurposes of determining a need for a ventricular pacemaker may bedisabled or turned “off” at block 410. Since a ventricular pacemaker isavailable to provide back-up ventricular pacing, the atrial pacemakermay monitor for atrial tachycardia (AT) or atrial fibrillation (AF)according to an implemented tachyarrhythmia detection algorithm (AT/AFDETECTION ON). The atrial duo operating mode may enable atrial ATPtherapy (ATRIAL ATP ON) in addition to providing bradycardia pacing.Without the ventricular pacemaker present, it may be undesirable todeliver atrial ATP since it could lead to an irregular ventricularrhythm. In response to detecting RV pacemaker 14, RA pacemaker 12 mayautomatically enable AT/AF detection and atrial ATP therapycapabilities.

During the duo operating mode, atrial bradycardia pacing may beconfigured to use a higher pacing pulse amplitude and/or pulse widththan used during the solo mode for bradycardia pacing. For example, theatrial pacing pulse amplitude may be increased by increasing a pacingsafety margin that is added to an atrial pacing capture threshold. Ahigher pacing safety margin may be used during the duo operating modecompared to the pacing safety margin used during the solo operatingmode. The higher atrial pacing pulse amplitude resulting from adding ahigher safety pacing margin promotes reliable sensing of the FF atrialpacing pulse by the ventricular pacemaker. Alternatively, a fixed highatrial pacing pulse amplitude or pulse width may be used during the duooperating mode that is expected to be above the atrial pacing capturethreshold and easily sensed by the ventricular pacemaker as a FF pacingpulse with a high degree of confidence. As such, the self-configured duooperating mode may include increasing the pacing safety margin asindicated at block 410 or otherwise setting a high atrial pacing pulseamplitude or pulse width.

Upon configuring the duo operating mode at block 410, the atrialpacemaker provides a signal to the programmer or other external device,e.g., upon the next interrogation command from the external device,indicating the duo operating mode has been configured and enabling theexternal device to display relevant programmable control parameters. Forexample, even if AT/AF detection and atrial ATP are enabled, a user maystill be able to turn these features on or off using the externalprogrammer. When turned on, relevant programmable control parameterssuch as AT/AF detection criteria and ATP control parameters may bedisplayed.

Some parameters or features included in the duo operating mode may benon-programmable parameters. For example, the increased atrial pacingpulse amplitude may be a fixed parameter so that a user may notinadvertently set the amplitude too low to be reliably sensed by theventricular pacemaker.

After switching to the duo operating mode, the atrial pacemaker maycontinue to monitor for the presence of the ventricular pacemaker. Ifthe ventricular pacemaker is no longer present (or functioning), theatrial pacemaker may return to the solo mode by returning to block 404.Detecting that the ventricular pacemaker is no longer present may bebased on receiving a notification from an external device or detecting adisappearance of FF ventricular pacing pulse sensed event signals from aFF sensing channel 224. An extended period time of no FF ventricularpacing pulse sensed event signals may be required to determine that theRV pacemaker 14 is no longer present compared to the time required todetect that RV pacemaker 14 is present based on sensing FF ventricularpacing pulses. For example, at least one day of no FF ventricular pacingpulse sensed events may be required before the RA pacemaker controlmodule 206 determines that the RV pacemaker 14 is no longer present. TheRV pacemaker 14 may be configured to deliver a predetermined number ofpacing pulses, e.g., 8 pacing pulses, at an overdrive pacing rategreater than an intrinsic heart rate and/or at a high pulse output atleast once per day to reduce the likelihood of RA pacemaker controlmodule 206 determining that RV pacemaker 14 is no longer present.Similarly, RA pacemaker 12 may be configured to deliver a predeterminednumber of pacing pulses at an overdrive rate and/or increased pulseoutput to reduce the likelihood that RV pacemaker 14 does not falselydetermine that RA pacemaker 12 is no longer present.

When a ventricular pacemaker, e.g., RV pacemaker 14 or an LV pacemaker,is implanted as indicated at block 420, it may initially determine if anatrial pacemaker is detected at block 422. Detection of an atrialpacemaker may be based on receipt of a telemetry notification signalfrom a programmer or other external device 20 or based on monitoring aventricular EGM signal for the occurrence of FF atrial pacing pulses.The ventricular pacemaker may be provided in a solo mode as a defaultmode or a duo mode as a default mode. If the atrial pacemaker isdetected at block 422, the ventricular pacemaker configures itself inthe duo operating mode (which may be a matter of maintaining a defaultmode) at block 430. The duo operating mode of the ventricular pacemakermay alter both monitoring and therapy delivery functions of theventricular pacemaker compared to the ventricular pacemaker solooperating mode.

For example, during the duo mode, the ventricular pacemaker may beconfigured to sense FF P-waves, which may include intrinsic or evokedP-waves, and FF atrial pacing pulses. The ventricular pacemaker may usethe sensed atrial events, including both FF sensed atrial pacing pulsesand FF sensed P-waves, for controlling the timing of the ventricularpacing pulses. As such, the ventricular duo operating mode configured atblock 430 includes enabling FF atrial pacing pulse sensing.

The duo operating mode may include the options of VVI(R) and VDD(R)pacing modes. Alternatively, the duo operating mode may include only theVDD(R) pacing mode. During VVI(R) pacing, a NF R-wave sensed during anescape interval inhibits a scheduled ventricular pacing pulse andrestarts the escape interval. FF atrial sensed events are not used toinhibit or trigger a ventricular pacing pulse. In the VDD(R) pacingmode, FF atrial sensed events, including FF atrial pacing pulse sensedevents and FF P-wave sensed events, are used to trigger a ventricularpacing pulse at an AV interval to provide atrial-synchronizedventricular pacing. The synchronized single-chamber VDD(R) pacing modeof ventricular pacemaker in combination with the AAI(R) pacing mode ofthe atrial pacemaker provide DDD(R) pacing. By sensing FF atrial eventsby sensing module 204 in the ventricular pacemaker, the two separateatrial and ventricular intracardiac pacemakers, e.g. pacemakers 12 and14, are enabled to provide DDD(R) pacing, which is described in greaterdetail below.

During the duo operating mode, the ventricular pacemaker pacing mode maybe programmable as a VVI(R) mode or a VDD(R) mode. When programmed in aVVI(R) mode (instead of VDD(R) mode), with an atrial pacemaker presentand operating in an AAI(R) mode, a DDI(R) mode is achieved (instead of aVDD(R) mode). The atrial pacemaker provides pacing and sensing in theatrial chamber and inhibits atrial pacing pulses in response to NFatrial sensed events. The ventricular pacemaker provides pacing andsensing in the ventricular chamber and inhibits ventricular pacingpulses in response to NF ventricular sensed events. The ventricularpacemaker is also enabled to sense FF atrial events but does not triggera ventricular pacing pulse at an AV delay in response to a FF atrialsensed event as it does during a VDD(R) mode. A DDI(R) pacing mode isuseful for patients with paroxysmal AF. An AV interval may be started inresponse to a FF atrial pacing pulse sensed event, but a FF non-pacedsensed event, i.e., an intrinsic FF P-wave sensed event, does not startan AV interval. The ventricular pacemaker paces the ventricle at theprogrammed lower rate or the sensor indicated rate interval when FFP-wave sense events signals are produced (corresponding to intrinsicP-waves) in the absence of FF atrial pacing pulse sensed events.

Self-configuration of the duo operating mode by the ventricularpacemaker may further include enabling atrial tachycardia/atrialfibrillation (AT/AF) detection by the ventricular pacemaker andautomatic pacing mode switching based on AT/AF detection, as indicatedin block 430. The ventricular pacemaker may automatically switch betweenVDD(R) and VVI(R) pacing modes based on AT/AF detection by theventricular pacemaker.

The atrial pacemaker may be enabled to detect the presence of AT/AFusing NF P-wave sensing (as indicated at block 410) but may not beconfigured to send a communication signal to the ventricular pacemakerto indicate that an AT/AF detection has been made. The ventriculardevice may configured during the duo mode to detect AT/AF based on adisappearance of both FF atrial pacing pulse sensed events and FF P-wavesensed events. P-waves during AF will be relatively low amplitudecompared to P-waves during sinus rhythm resulting in a loss of P-wavesensing or intermittent P-wave sensing. In some cases, FF P-wave sensedevent signals could be produced at a high rate by the ventricularpacemaker sensing module during AF if the P-wave amplitude is highenough during AF. Accordingly, the ventricular pacemaker may be enabledto detect AF during a duo operating mode based on AF detection criteriawhich may include FF sensed event signals occurring below a minimumrate, no FF sensed event signals for a predetermined interval of time,and/or a FF P-wave sensed event signal rate that is greater than apredetermined pacing mode switch threshold rate.

Alternatively, the atrial pacemaker may be configured to detect AF anddeliver atrial pacing pulses at a particular rate or sequence to signalthe ventricular pacemaker that AF has been detected. The ventricularpacemaker detects AF in response to sensing the FF atrial pacing pulseevents at the particular rate or sequence.

When AF is detected by the ventricular pacemaker, the control module 206automatically switches the VDD(R) pacing mode to the VVI(R) pacing mode.A return of FF sensed event signals produced by the FF sensing channel224 at a rate greater than a minimum rate and below a mode switchthreshold rate causes the ventricular pacemaker control module 206 toreturn the pacing mode to VDD(R). In this way, the separate atrialpacemaker and ventricular pacemaker can operate cooperatively to providedual chamber pacing in patients having AF by providingatrial-synchronized ventricular pacing, i.e., DDD(R) pacing, when AF isnot detected by the ventricular pacemaker and DDI(R) pacing when AF isdetected.

The ventricular duo operating mode may include other monitoringfunctions. For example, an AV conduction time (AVCT) test may be enabledat block 430. An AVCT test may be performed periodically to determine ifAV conduction is intact in a patient that may have varying degrees of orintermittent AV block. The ventricular pacemaker control module 206 mayperiodically extend an AV interval being used to control the timing ofventricular pacing pulses following sensed FF atrial events to allowtime for an intrinsic R-wave to be sensed. The time interval between asensed FF atrial event, which may be a FF atrial pacing pulse sensedevent or a FF P-wave sensed event, and a subsequently sensed NF R-waveis determined as the AV conduction time.

The duo operating mode configured at block 430 may further includeenabling minimum ventricular pacing (MVP). The AVCT test enabled atblock 430 may be used by the ventricular pacemaker control module 206 tocontrol MVP according to when AVCT is within an acceptable range. IfAVCT is within an acceptable normal range, the ventricular pacemakerswitches to atrial-based pacing in which ventricular pacing is withheldand only back-up ventricular pacing pulses are delivered at a relativelylong AV interval, which may be a long paced AV (P-AV) interval followingan atrial pacing pulse sensed as a far field pacing pulse event or along sensed AV (S-AV) interval following a far field P-wave sensedevent. For example, the ventricular pacing mode may be a VDD(R) modewith a longer AV interval than when AVCT is not within a predeterminedacceptable range. The atrial-based pacing minimizes the number ofventricular pacing pulses being delivered and promotes ventriculardepolarization by the natural conduction system of the heart via the AVnode. If one or more back-up ventricular pacing pulses are delivered, orif the AVCT is determined to be longer than an acceptable normal rangeduring atrial-based pacing, the ventricular pacemaker control moduleswitches to atrial-synchronized ventricular pacing at a desired AVinterval following sensed FF atrial events (FF atrial pacing pulsesensed events or FF P-wave sensed events). Sensing of FF atrial eventsby the ventricular pacemaker in the duo operating mode is described ingreater detail below.

Periodically, the ventricular pacemaker may extend the AV intervalduring atrial-synchronized ventricular pacing according to the AVCT testprotocol to detect a return of AV conduction within a normal range. Theventricular pacemaker may switch back to atrial-based pacing in responseto the return of AVCT to a normal range. While the AVCT test and MVPfeatures may be enabled during the duo operating mode of the ventricularpacemaker, each feature may be programmably turned on or off by a useraccording to individual patient need. Other relevant operatingparameters may be made accessible to a user on the programmer or otherexternal device, for example for programming a desired AV intervalduring atrial-triggered ventricular pacing for optimizedatrioventricular synchrony and a relatively longer AV interval fordelivering back-up ventricular pacing pulses during atrial-based MVP.

In the duo operating mode, the combination of the atrial pacemaker andthe ventricular pacemaker operate together in a DDD(R) or DDI(R) modeeven though neither device is delivering pacing pulses to both theatrial and ventricular chambers and neither device is sensing NF signalsin both the atrial and ventricular chambers. The atrial pacemaker isoperating in an AAI(R) pacing mode and the ventricular pacemaker isoperating in a VDD(R) pacing mode or a VVI(R) pacing mode with the addedfunctionality of sensing FF atrial events to provide the pseudo dualchamber sensing and desired response to FF sensed events (atrial pacedsensed events or P-wave sensed events). Together the two devices operatein a DDD(R) or DDI(R) pacing mode and thus provide a wholly intracardiacDDD(R) or DDI(R) pacing system.

If the atrial pacemaker is not detected by the ventricular pacemaker atblock 422, upon initial implant or at any later time during the duooperating mode, the ventricular pacemaker self-configures in a solooperating mode at block 424. For example, if the ventricular pacemakerno longer detects FF atrial pacing pulses for a predetermined intervalof time or receives a wireless telemetry notification signal from anexternal device indicating the atrial pacemaker is not present (at block422), the ventricular pacemaker self-configures the solo operating modeat block 424.

In the solo mode configured at block 424, the sensing module 204 of theventricular pacemaker may be enabled to sense ventricular R-waves onlywith VVI(R) being the only pacing mode available. Alternatively, thesensing module may be enabled to sense ventricular R-waves and FFP-waves with both VVI(R) and VDD(R) pacing modes available.

In the solo operating mode, therefore, both atrial-asynchronousventricular pacing and atrial-synchronous ventricular pacing using FFP-wave sensing may be available. As indicated above, single chamberventricular pacing with pseudo dual chamber sensing based on FF P-wavesensing is referred to herein as VDD(R) since pacing pulses aredelivered in the ventricle, near-field R-waves and far-field P-waves aresensed in the ventricular and atrial chambers, respectively, using asingle bipole of the single chamber device, and a dual response tosensed events is provided. The ventricular pacing pulse is inhibited inresponse to a NF R-wave sensed event signal during an AV interval, and aventricular pacing pulse is triggered in response to a FF P-wave sensedevent signal. In the solo operating mode, therefore, two differentpacing modes may be selectable using external device 20. For example, aclinician or other user may be able to program the RV pacemaker 14 inFIG. 1 to a VVI(R) mode or VDD(R). Both options may be made availablewith corresponding programmable therapy control parameter settings, suchas a lower rate for controlling ventricular pacing rate during theVVI(R) pacing mode and the AV interval for controlling theatrial-synchronized pacing pulses during VDD(R) pacing mode.

If the atrial pacemaker is detected during the solo mode at block 422,the ventricular pacemaker switches to the duo mode at block 430. Theventricular pacemaker may detect the presence of the atrial pacemaker inresponse to a wireless telemetry signal from an external device 20.Alternatively, the ventricular pacemaker solo operating mode may includemonitoring FF atrial events periodically or continuously to detect FFatrial pacing pulses and thereby detect the presence of the atrialpacemaker.

An intracardiac pacemaker, atrial or ventricular, operating in a solo orduo mode may be configured to periodically deliver pacing pulses at anincreased pacing pulse output, e.g., increased pulse amplitude and/orrate, to facilitate automatic detection of the pacemaker by anotherintracardiac pacemaker. For example, the atrial pacemakerself-configured in a solo operating mode at block 404 may periodicallyincrease the atrial pacing pulse amplitude and/or periodically overdrivepace the atria if no atrial pacing pulses have been delivered for apredetermined interval of time. If no FF atrial pacing pulses are sensedby the ventricular pacemaker for an extended period of time due tosustained atrial sensing inhibiting the atrial pacing pulses, theventricular pacemaker may incorrectly detect the removal or absence ofthe atrial pacemaker. Similarly, if no FF ventricular pacing pulses aresensed by the atrial pacemaker for an extended period of time due toventricular sensed events inhibiting ventricular pacing pulses, theatrial pacemaker may incorrectly detect the removal or absence of theventricular pacemaker.

As such, each pacemaker may be configured to periodically deliver pacingpulses at a rate that is greater than the intrinsic events, byshortening an appropriate pacing timing interval based on an atriallower rate or SIR, ventricular lower rate or SIR, or AV interval.Periodic pacing at an interval shorter than intrinsic cardiac eventintervals promotes FF sensing of pacing pulses by another pacemaker andthereby maintains detection of the presence of one pacemaker by theother pacemaker. In other examples, pacing pulses may be delivered in aparticular sequence by varying the pacing intervals in a particular wayso that the FF pacing pulse sensed event signals produced by FF sensingchannel 224 can be easily identified by the control module 206 asevidence of the presence of the other pacemaker.

In various embodiments, the pacing pulses sensed as FF pacing pulseevents by the first pacemaker are therapeutic pacing pulses delivered inanother heart chamber by another intracardiac pacemaker. The therapeuticpacing pulses are sensed by the first pacemaker as FF pacing pulseevents for detecting the presence of the other pacemaker as opposed tonon-therapeutic communication signals transmitted by the other pacemakerto the first pacemaker.

FIG. 6 is a functional block diagram 450 of sensing and pacing controlmodules included in intracardiac pacemaker 100 according to one example.In this illustrative embodiment, the functionality represented bydiagram 450 is described with reference to a ventricular intracardiacpacemaker such as RV pacemaker 14 configured to sense FF atrial pacingpulses, FF atrial P-waves associated with intrinsic or evokeddepolarizations of the atria, and NF R-waves. It is recognized that thefunctionality can be adapted to be included in an atrial intracardiacpacemaker for sensing FF ventricular pace signals, FF R-waves and NFP-waves.

A single bipolar pair of electrodes 162 and 164 is used for sensing theFF and NF events and for delivering ventricular pacing pulses in thisexample. As described above in conjunction with FIGS. 2B and 2C, theinter-electrode spacing may be increased by an extender to improvesensing of FF signals. The EGM signal developed across electrodes 162and 164 is received by a wide-band analog filter, pre-amplifier anddigital converter (DC) circuit 452. The digital output of circuit 452 isprovided to three sensing channels 454, 456 and 458.

Each of the sensing channels 454, 456 and 458 may include differentdigital filters and cardiac event detectors to enhance sensing differentevents by each channel based on amplitude threshold crossings. Forexample, FF P-wave sensing channel 456 may be provided with a differentbandpass filter and sensing threshold than R-wave sensing channel 458 topromote reliable sensing of FF P-waves and NF R-waves by the respectivesensing channels 456 and 458. In other examples, FF-P-wave sensingchannel 456 and/or NF sensing channel 458 may be configured to sense FFP-waves and NF R-waves using other criteria than a sensing thresholdcrossing, such as waveform morphology criteria. Upon a P-wave sensingthreshold crossing (or other sensing threshold criteria being met), FFP-wave sensing channel 456 produces an atrial sense (AS) signal (alsoreferred to herein as a FF P-wave sensed event signal) that is passed tothe pace timing and control 460.

The R-wave sensing channel 458 produces a ventricular sense (VS) signal(also referred to herein as a NF R-wave sensed event signal) that ispassed to pace timing and control 460 in response to the EGM signalreceived from circuit 452 crossing an R-wave sensing threshold. If thecurrent pacing mode is VVI(R), the VS signal will inhibit a ventricularpacing pulse and restart a pacing escape interval. Pace timing andcontrol 460 will start a lower rate or SIR pacing escape interval inresponse to the VS signal and produce a VP signal if the escape intervalexpires before another VS signal is received. The VP signal is passed tothe pulse generator 202 (not shown in FIG. 6) to cause delivery of aventricular pacing pulse. If the current pacing mode is VDD(R), the VSsignal will inhibit a ventricular pacing pulse and restart a lower rateor SIR pacing escape interval. If no AS signal is received from FFP-wave sensing channel 456 before expiration of the lower rate or SIRpacing escape interval, a ventricular pacing pulse is delivered. If anAS signal is received from FF P-wave sensing channel 456, pace timingand control 460 starts an AS-V interval to trigger ventricular pacingpulse delivery upon expiration of the AS-V interval. If a VS signal isreceived from R-wave sensing channel 458 during the AS-V interval, thepace timing and control inhibits the scheduled ventricular pacing pulseand restarts the lower rate or SIR escape interval.

The FF Apace sensing channel 454 is configured to produce a FFAP sensesignal (also referred to herein as a FF atrial pacing pulse sensed eventsignal) in response to sensing a FF atrial pacing pulse. The FF Apacesensing channel 454 may include a narrow bandpass filter for passing afrequency characteristic of the atrial pacing pulse artifact. FF Apacesensing channel 454 may be configured to sense the atrial pacing pulsebased on frequency content, slew rate, amplitude, pacing pulse artifactmorphology, an over-range signal from the pre-amplifier in circuit 452,saturation of the digital convertor in circuit 452, or any combinationthereof. FF Apace sensing channel 454 may correspond to apparatus andmethods for sensing a pacing pulse delivered in another heart chamber asgenerally disclosed in provisionally-filed U.S. Pat. Application No.61/984,249, hereby incorporated herein by reference in its entirety.

As further described below in conjunction with FIGS. 7 and 8, the pacetiming and control 460 included in the pacemaker control module 206 isconfigured to select between a sensed AV interval (SA-V interval) and apaced AV interval (PA-V interval) for providing atrial synchronizedventricular pacing in a VDD(R) pacing mode. The SA-V interval is startedin response to receiving an AS signal from FF P-wave sensing channel456. The PA-V interval is started in response to receiving a FFAP signalfrom FF Apace sensing channel 454.

When the ventricular pacemaker is operating in a VVI(R) pacing mode, theFF Apace sensing channel 454 and the FF P-wave sensing channel 456 maybe disabled or any FFAP and AS signals may be ignored by pace timing andcontrol 460. If the ventricular pacemaker is configured in the solooperating mode with a VDD(R) pacing mode selected, the FF P-wave sensingchannel 456 may be enabled to provide atrial-synchronized ventricularpacing. The FF Apace sensing channel 454 may be disabled or ignored bypace timing and control 460 since no atrial pacemaker is present toproduce atrial pacing pulses during the solo operating mode of theventricular pacemaker. The FF Apace sensing channel 454 may be enabled,periodically or continuously during the solo operating mode, however, toprovide FFAP signals to the control module 206 of the ventricularpacemaker for the purpose of monitoring for the presence of an atrialintracardiac pacemaker.

When the ventricular pacemaker is configured in the duo operating modewith VDD(R) pacing, both the FF Apace sensing channel 454 and the FFP-wave sensing channel 456 are enabled and FFAP signals and AS signalsreceived by pace timing and control 460 are used for setting respectivePA-V intervals and SA-V intervals. When the pace timing and control 460receives a FFAP signal, a subsequent AS signal during the PA-V intervalis ignored. The AS signal may be produced in response to sensing anevoked P-wave following the FFAP signal. A P-wave sensing blankingwindow may be applied to FF P-wave sensing channel 456 in some examplesfor preventing an evoked P-wave from causing an AV interval to berestarted (i.e., an SA-V interval to be started during a PA-V interval)before delivering a pacing pulse at the PA-V interval.

Depending on the orientation of the atrial pacemaker and the ventricularpacemaker relative to one another, the atrial pacing pulse may notalways be sensed by the ventricular pacemaker. For example, it isexpected that when a RA pacemaker is substantially orthogonal to the RVpacemaker, sensing of the FF atrial pacing pulses is minimized. Therelative orientation of the RA and RV pacemakers may be unknown and maychange over time, e.g., due to respiration, posture or other motion. Assuch, the RV pacemaker may sense the FF atrial pacing pulse at times andat other times may sense the FF evoked P-wave. When the FF atrial pacingpulse is not sensed, the evoked P-wave sensed by the FF P-wave sensingchannel 456 will cause an SA-V interval to be started by pace timing andcontrol 460. Since the evoked response P-wave occurs upon atrialdepolarization, the SA-V interval provides the proper timing of theventricular pacing pulse for desired AV synchrony whether the AS signalis produced in response to sensing an intrinsic or an evoked FF P-wave.

When the atrial pacing pulse is sensed earlier than the evokeddepolarization of the atrium, however, using the SA-V interval wouldcause the ventricular pacing pulse to be delivered earlier than thedesired AV interval. Early contraction of the ventricle may truncateventricular filling. As such, the PA-V interval, set longer than theSA-V interval, is selected in response to the FFAP signal. Otherwise theSA-V interval is selected in response to either an intrinsic or evokedFF P-wave, which may not be distinguished from each other by FF P-wavesensing channel 456.

In another example, the FFAP signal from FF Apace sensing channel 454may cause pace timing and control 460 to set a short blanking intervalthen sense the evoked P-wave by FF P-wave sensing channel and start theSA-V interval in response to the AS signal. The FFAP signal is not usedto start an AV interval but is used to prevent the pace artifact frombeing detected as an evoked FF P-wave and to indicate when to startlooking for the evoked FF P-wave signal.

FIG. 7 is a timing diagram 470 depicting the operation of RA pacemaker12 and RV pacemaker 14 when configured in duo operating modes. The RApacemaker 12 delivers an atrial pacing (AP) pulse 472, starts a lowerrate (or SIR) escape interval 475, and delivers a next AP pulse 476 uponexpiration of the escape interval 475. An atrial evoked response (ER)474 caused by pacing pulse 472 may be ignored by the RA pacemaker byapplying a blanking or refractory period 473 following AP 472 so thatthe escape interval 475 is not restarted in response to ER 474.

The RV pacemaker 14 senses the FF atrial pacing pulse and produces a FFatrial pacing pulse sensed event signal (FFAP) 480 that starts a PA-Vinterval 490. If an AS signal 482 is produced in response to sensing theER 474 by the FF P-wave sensing channel (456 in FIG. 6), it does notcause an AS-V interval to be started during the PA-V interval 490. Insome examples, a P-wave refractory period 484 may be applied followingthe FFAP signal 480 to ignore AS events that are likely to be evokedP-waves following the FFAP 480. If a NF R-wave is not sensed by the RVpacemaker during the PA-V interval 490, a ventricular pacing pulse (VP)492 is delivered at the expiration of PA-V interval 490.

At expiration of the atrial escape interval 475, an AP 476 is deliveredfollowed by an ER 478. In this case, the AP 476 is not sensed by theventricular pacemaker, however the FF evoked P-wave corresponding to ER478 is sensed as an AS event 486 by the FF P-wave sensing channel 456.An SA-V interval 494, that is shorter than PA-V interval 490, is startedby the pace timing and control module (460 in FIG. 6) in response to theAS 486. Ventricular pacing pulse VP 496 is delivered upon expiration ofthe SA-V interval 494.

An intrinsic P-wave 479 occurs during the next atrial escape interval475′. The P-wave 479 is sensed as a FF AS event 488 by the RV pacemaker14. The RV pacemaker 14 starts the SA-V interval 494′ and delivers asubsequent VP 498 at the same AV interval after intrinsic P-wave 479 asafter the ER 478. By proper selection of a PA-V or SA-V interval by pacetiming and control 460, each of VP 492, VP 496, and VP 498 are deliveredat the same effective AV interval following atrial depolarizationwhether the depolarization is an evoked response 474 or 478 or anintrinsic P-wave 479 and regardless whether the atrial pacing pulse 472,476 is sensed or not. The P-AV and the S-AV intervals may each take intoaccount any delay in sensing the FF atrial events by the RV pacemaker14.

FIG. 8 is a flow chart 500 of a method for controlling ventricularpacing by an intracardiac ventricular pacemaker, such as RV pacemaker 14shown in FIG. 1. At block 501, the RV pacemaker 14 self-configures ineither a solo or duo operating mode. Control module 206 self-configuresthe solo mode when no other implanted intracardiac pacemaker is present.The RV pacemaker 14 configures itself in a duo mode when an atrialintracardiac pacemaker, such as RA pacemaker 12, is present.

If the ventricular pacemaker operating mode is a solo mode (“yes” branchof block 501), the control module 206 may enable either a VVI(R) pacing(atrial asynchronous) or VDD(R) pacing (atrial synchronous) mode. A usermay selectively program the pacing mode desired to be in effect duringthe solo operating mode. At block 502, the control module 206 determinesif the currently programmed pacing mode is VVI(R) or VDD(R).

If the programmed pacing mode is VVI(R), the control module 206 starts alower rate (or SIR) pacing escape interval to control a lowerventricular pacing rate at block 503. The escape interval is started inresponse to a delivered ventricular pacing pulse or in response tosensing a NF R-wave by the sensing module 204. If an R-wave is sensed atblock 504 prior to the escape interval expiring, the escape interval isrestarted at block 503. If an R-wave is not sensed prior to the escapeinterval expiring, a ventricular pacing pulse is delivered at block 505at the expiration of the escape interval. The escape interval set atblock 503 may be adjusted according to a sensor-indicated pacing rate tomeet the metabolic needs of the patient, based for example on a patientactivity signal received from an accelerometer.

The ventricular intracardiac pacemaker may remain in this VVI(R) pacingmode as long as the solo operating mode remains (as determined at block501) and the programmed pacing mode remains VVI(R) (as determined atblock 502).

The ventricular pacemaker may be programmed to operate in a VDD(R)pacing mode during the solo operating mode. The VDD(R) pacing modeincludes delivering pacing pulses in the ventricle, pseudo dual chambersensing by sensing both NF ventricular events and FF atrial events, andproviding a dual pacing response to sensed events wherein pacing pulsesare triggered by a FF atrial event and inhibited by sensing a NFventricular event. The ventricular rate may be controlled in arate-responsive manner based on a patient activity signal.

If the programmed pacing mode is VDD(R) during the solo operating mode(affirmative result at decision block 502), atrial-synchronizedventricular pacing is delivered. A patient may have normal sinus nodefunction with AV conduction block requiring ventricular pacing. Thesepatients may benefit from atrial-synchronized ventricular pacingrequiring only an intracardiac ventricular pacemaker. When a FF P-waveis sensed at block 506, the control module 206 starts an AV interval atblock 507.

If a NF R-wave is sensed at block 508, the ventricular pacing pulsescheduled to occur upon the expiration of the AV interval is inhibitedat block 511 by starting a VV pacing escape interval set according tothe lower rate (LR) or SIR. The control module 206 waits for the next FFP-wave sensed event at block 506. If no FF P-wave is sensed at block 506before expiration of the VV pacing escape interval, a ventricular pacingpulse is delivered by pulse generator 202 at block 510.

If the AV interval started at block 507 in response to a sensed FFP-wave expires without sensing a NF R-wave at block 508, a ventricularpacing pulse (VP) is delivered at block 509 at the expiration of the AVinterval. After delivering the VP, the control module 206 starts a VVpacing escape interval and waits for the next FF P-wave sensed event atblock 506. All FF P-wave events sensed at block 506 are intrinsicP-waves since an atrial pacemaker is not present in this case. The VDDRpacing mode may be achieved by the intracardiac pacemaker positionedwholly in the ventricle and using a single bipolar pair of electrodesfor delivering the ventricular pacing pulses, sensing the NF R-waves andthe FF P-waves.

If the RV pacemaker 14 is operating in a duo operating mode (negativeresult at block 501), the RV pacemaker 14 monitors the EGM signalreceived by the sensing module 204 for a FF atrial pacing pulse event atblock 512. For the sake of the flow chart 500, it is assumed that duringthe duo operating mode, the RV pacemaker 14 is programmed to deliverVDD(R) pacing, by default or by user selection. It is recognized,however, that depending on patient need, a VVI(R) pacing mode may stillbe available and programmed by a user during the duo operating mode, inwhich case the flow of blocks 503 through 505 would be followed.

In the duo operating mode with VDD(R) pacing mode programmed, if a FFatrial pacing pulse event is sensed at block 512, a PA-V interval isstarted at block 513. During the duo operating mode, the RV pacemakercontrol module 206 selects between an SA-V interval and an PA-V intervalbased on whether the FF sensing channel 224 has produced a FF atrialpacing pulse sensed event signal, as determined at block 512, or a FFP-wave sensed event signal as determined at block 520. The PA-V intervalis started at block 513 in response to an affirmative result at decisionblock 512, and the SA-V interval is started at block 522 in response toan affirmative result at decision block 520. The PA-V interval istypically longer than the SA-V interval since there will be a shortdelay between delivery of the atrial pacing pulse and the evokedresponse of the atrium, though there may be cases that the PA-V isshorter than the SA-V depending on the relative conduction times of theatrial evoked response and the intrinsic atrial depolarization to theventricle. If a NF R-wave is sensed during the PA-V interval at block514, the ventricular pacing pulse is inhibited at block 518. The controlmodule 206 restarts a LR or SIR escape interval at block 530 and waitsfor the next FF atrial sensed event at blocks 512 and 520, a FF atrialpacing pulse sensed event or a FF P-wave sensed event, whichever comesfirst. If the PA-V interval expires without sensing a NF R-wave at block514, a ventricular pacing pulse is delivered at block 516 uponexpiration of the PA-V interval.

If the next atrial sensed event is a FF P-wave, as determined atdecision block 520, the control module 206 starts an SA-V interval atblock 522. If a NF R-wave is not sensed prior to expiration of the SA-Vinterval (block 524), a ventricular pacing pulse is delivered by pulsegenerator 202 at block 526 upon expiration of the SA-V interval. If a NFR-wave is sensed during the SA-V interval (block 524), the ventricularpacing pulse is inhibited at block 528. The control module restarts a LRor SIR escape interval at block 532 and waits for the next sensed atrialevent at block 512 or block 520. In this way, the RV pacemaker 14selects from a PA-V interval or an SA-V interval based on whether the FFsensed atrial event is a FF sensed atrial pacing pulse (block 512) or aFF sensed P-wave (block 520). The resulting ventricular pacing pulsesare delivered at a desired AV interval following the atrialdepolarization, whether it is an evoked response or an intrinsicdepolarization.

If neither a FF atrial pacing pulse nor a FF P-wave is sensed at blocks512 or 520 during a LR or SIR escape interval started at blocks 530 or532, the ventricular pacemaker delivers the ventricular pacing pulseupon expiration of the escape interval at block 534. A new escapeinterval is started at block 530 in response to the ventricular pacingpulse, and the control module 206 waits for the next FF sensed event atblocks 512 and 520.

During the atrial-synchronized ventricular pacing delivered by RVpacemaker 14 in the duo operating mode, the RA pacemaker 12 may beoperating as an AAI pacemaker for pacing in the RA, sensing RA EGMsignals, and inhibiting a RA pacing pulse in response to sensing aP-wave prior to the expiration of an atrial pacing escape interval. TheRA pacemaker 12 operating as an AAI(R) pacemaker and the RV pacemakeroperating as a VDD(R) pacemaker achieves DDD(R) pacing therapy deliveredto the patient. The VDD(R) pacing is responsive to dual chamber sensingeven though no sensing electrodes positioned in the atria are coupleddirectly to the RV pacemaker. Dual chamber sensing is achieved bysensing FF atrial events from the ventricular EGM signal. The FF atrialevents may include atrial pacing pulses delivered by the RA pacemakerand FF P-waves, intrinsic or evoked. Thus a dual response ofatrial-triggered ventricular pacing with ventricular pacing pulsesinhibited by NF R-waves is achieved. A synchronized single chamberpacing mode is therefore available in both solo and duo operating modeswhere the single chamber pacing, in this case ventricular pacing, issynchronized to FF sensed events, in this case FF atrial events forachieving atrial-synchronized ventricular pacing.

FIG. 9 is a conceptual diagram of another example of an IMD system 10′including multiple, self-configuring intracardiac pacemakers and otherimplantable, extracardiac devices. IMD system 10′ is shown to include RApacemaker 12 and RV pacemaker 14 as previously shown in FIG. 1. OtherIMDs that may be implanted in a patient include an LV intracardiacpacemaker 16 and extracardiac IMDs, such as ECG monitor 50 and ICD 60,which may be subcutaneously implanted devices. It is recognized that allof the IMDs 12, 14, 16, 50 and 60 may not be implanted in a singlepatient 6. Rather, the various intracardiac pacemakers 12, 14 and 16 andthe extracardiac ECG monitor 50 and ICD 60 are shown to illustrate thevarious types of implantable devices that may be implanted to monitor apatient's heart 8 and/or deliver one or more therapies to heart 8.

ECG monitor 50 includes housing-based electrodes 52 for sensing asubcutaneous ECG signal for use in diagnosing a cardiac condition. ECGmonitor 50 may correspond to the REVEAL® Insertable Loop Recorder,available from Medtronic, Inc., Minneapolis, Minn.

ICD 60 is shown coupled to a subcutaneous lead 70 which may carrysensing electrodes 72 and 76 for detecting tachyarrhythmias of heart 8and a defibrillation electrode 74 for delivering high voltagecardioversion/defibrillation shock pulses to heart 8 in response todetecting tachycardia or fibrillation. ICD 60 and lead 70 may correspondto a subcutaneous ICD and lead system as generally disclosed in U.S.patent application Ser. No. 14/198,058 (Olson), hereby incorporatedherein by reference in its entirety, or the above-incorporated '785patent (Crutchfield). In other examples, ICD 60 may be coupled to asubsternal, transvenous or other lead and electrode configuration.

Each of pacemakers 12, 14 and 16 include a control module capable ofself-configuring an operating mode, in a solo, duo or trio operatingmode, to establish available pacing modes, monitoring functions andassociated programmable parameters of the pacemaker 12, 14 or 16 inresponse to establishing the presence of other ones of pacemaker 12, 14or 16 as generally described in conjunction with FIG. 4 above. Inaddition, the control modules of each of pacemakers 12, 14 and 16 may beconfigured to modify a currently configured solo, duo or trio operatingmode in response to establishing the presence of another implantablemedical device besides an intracardiac pacemaker.

For example, RA pacemaker 12 may be capable of configuring itself in asolo operating mode, a modified solo operating mode in the presence ofICD 60, and a modified solo operating mode in the presence of ECGmonitor 50. RA pacemaker 12 may be further capable of self-configuring aduo operating mode when the presence of a ventricular intracardiacpacemaker (RV or LV pacemaker 14 or 16) is present, a modified duo modewhen a ventricular pacemaker 14 or 16 is present and ICD 60 is presentand a modified duo mode when ventricular pacemaker 14 or 16 is presentand ECG monitor 50 is present, and so on.

With each IMD added to the system 10′ implanted in patient 6, the RApacemaker 12 may establish an existing solo, duo or trio operating modebased on whether another pacemaker 14 or 16 is present and modify theestablished solo, duo or trio mode based on the presence of another IMD50 or 60. A currently configured operating mode is modified when an IMDother than an intracardiac pacemaker is implanted by enabling ordisabling a feature, adjusting a therapy delivery or monitoring controlparameter, or enabling programmability of a control parameter by a userinteracting with an external device 20. The operating mode is modifiedto disable functions that may be redundant between an intracardiacpacemaker 12, 14 or 16 and an extracardiac IMD 50 or 60 to conservebattery energy in the intracardiac pacemaker. The operating mode mayadditionally or alternatively be modified to add features which takeadvantage of the presence of an extracardiac, e.g., a subcutaneouslyimplanted, IMD.

For example, RA pacemaker 12 may enable AV block monitoring in a solooperating mode for detecting a need for RV pacemaker 14 due todevelopment of AV conduction block. AV block monitoring by RA pacemaker12 may be disabled in a modified solo operating mode when ECG monitor 50is present. ECG monitor 50 may be capable of collecting the data neededfor monitoring AV block for determining a need for an RV pacemaker 14.Disabling AV block monitoring in RA pacemaker 12 during the solo modewill conserve battery life of the RA pacemaker 12.

In another example, a ventricular intracardiac pacemaker 14 or 16 mayself-configure a duo operating mode for delivering DDD(R) pacing inconjunction with RA pacemaker 12 as described above. In one example, ifboth RV pacemaker and LV pacemaker are present with RA pacemaker 12, RVpacemaker may be self-configured in a trio operating mode that includesonly right ventricular back up pacing, e.g., in a VVI mode. LV pacemaker16 may be self-configured in a trio operating mode that includes VVI(R)and VDD(R) programmable pacing modes to provide atrial-synchronized LVpacing, with the RV pacemaker providing only back up RV pacing.

If ICD 60 is present, the ventricular pacemaker 14 or 16 may modify itsself-configured operating mode to add ventricular tachycardia (VT)detection and ventricular ATP therapy delivery. For example, VTdetection and ventricular ATP therapy may be available in the solo, duoor trio mode with FF atrial event sensing enabled since it may bedesirable to discriminate VT from supraventricular tachycardia (SVT)using FF atrial sensed events. Ventricular ATP may be undesirablewithout the capability of cardioversion or defibrillation shock therapyprovided by ICD 60 since VT could accelerate or deteriorate intoventricular fibrillation (VF).

As such, a modified solo, duo or trio operating mode of RV pacemaker 14or LV pacemaker 16 may add ventricular ATP or other therapies that theintracardiac pacemaker 14 or 16 is capable of delivering but is notnormally enabled to do so when ICD 60 is not present due to patientsafety or other concerns. Various examples of VT detection and ATPtherapies that may be implemented in a ventricular intracardiacpacemaker 14 or 16 are generally disclosed in commonly-assigned U.S.Pat. No. 7,515,960 (Sharma), U.S. Pat. No. 7,149,577 (Sharma, et al.),U.S. Pat. No. 7,623,911 (Sarkar, et al.), U.S. Pat. No. 7,742,812(Ghanem, et al.), and U.S. Pat. No. 8,401,629 (Stadler, et al.), all ofwhich patents are hereby incorporated herein by reference in theirentirety.

Any of the intracardiac pacemakers 12, 14 or 16 may establish thepresence of an extracardiac IMD 50 or 60 in response to an RF telemetrynotification signal received from external device 20. Alternatively,intracardiac pacemakers 12, 14 or 16 may be configured to receive acommunication signal from an extracardiac IMD 50 or 60 by an ultrasonicbody bus communication signal as generally disclosed in U.S. Pat. No.5,113,859 (Funke), hereby incorporated herein by reference in itsentirety.

Thus, various examples of an implantable medical device system have beendescribed according to illustrative embodiments. However, one ofordinary skill in the art will appreciate that various modifications maybe made to the described embodiments without departing from the scope ofthe following claims.

The invention claimed is:
 1. An implantable medical device system,comprising a first implantable medical device that is configured to beimplanted in a patient; the first implantable medical device comprisinga first control module configured to: control operations of the firstimplantable medical device according to an operating mode of the firstcontrol module; establish whether a second implantable medical device isfunctionally present or absent in the patient; and self-configure thefirst control module between a first operating mode in response toestablishing that the second implantable medical device is functionallypresent and a second operating mode in response to establishing that thesecond implantable medical device is functionally absent, wherein,according to configuration of the first control module, the secondimplantable medical device is functionally absent on condition that abattery of the second implantable medical device has reached a statewhere the second implantable medical device is non-functional in theimplantable medical device system.
 2. The system of claim 1, wherein thefirst implantable medical device comprises: a first sensing modulecoupled to a pair of electrodes, the first sensing module comprising anear-field sensing channel configured to produce first sensed eventsignals in response to events occurring in a first heart chamber and afar-field sensing channel configured to produce second sensed eventsignals in response to events occurring in a second heart chamber; thefirst control module configured to establish whether the secondimplantable medical device is present in response to the second sensedevent signals received from the far-field sensing channel.
 3. The systemof claim 2, wherein the far-field sensing channel is configured to sensepacing pulses delivered by the second implantable medical device andproduce far-field pacing pulse event signals, the first control modulebeing enabled to establish that the second implantable medical device ispresent in the patient based on the second sensed event signalscomprising sensed far-field pacing pulse event signals.
 4. The system ofclaim 2, further comprising the second implantable medical device,wherein the second implantable medical device comprises: a secondsensing module coupled to a pair of electrodes and comprising anear-field sensing channel producing first sensed event signals and afar-field sensing channel producing second sensed event signals; apacing pulse generator coupled to the pair of electrodes; wherein thesecond implantable medical device is configured to self-configure byenabling selectable pacing modes comprising an asynchronous pacing modeand a synchronous pacing mode, the asynchronous pacing mode beingselectably enabled for controlling pacing pulses to the second heartchamber based on the first sensed event signals received from thenear-field sensing channel of the second sensing module but not based onthe second sensed event signals received from the far-field sensingchannel of the second sensing module, the synchronous pacing mode beingselectably enabled for controlling pacing pulses delivered to the secondheart chamber in response to the second sensed event signals receivedfrom the far-field sensing channel of the second sensing module and thefirst sensed event signals received from the near-field sensing channelof the second sensing module.
 5. The system of claim 1, wherein thefirst implantable medical device comprises a pulse generator coupled toa pair of electrodes; wherein self-configuring the first operating modeby the first control module comprises selecting a first setting of apacing pulse output parameter for controlling pacing pulses delivered bythe pulse generator via the pair of electrodes, wherein self-configuringthe second operating mode by the first control module comprisesselecting a second setting of the pacing pulse output parameter that isused at least periodically for controlling pacing pulses delivered bythe pulse generator, the second setting being different than the firstsetting.
 6. The system of claim 1, wherein the first implantable medicaldevice comprises: a sensing module coupled to a pair of electrodes, thesensing module comprising a near-field sensing channel producing firstsensed event signals and a far-field sensing channel producing secondsensed event signals; wherein the first control module is configured todetermine a need for the second implantable medical device in responseto the second sensed event signals when the first control module isself-configured in the first operating mode.
 7. The system of claim 1,wherein the first control module is further configured to self-configurethe second operating mode by enabling tachyarrhythmia detection and atachyarrhythmia therapy.
 8. The system of claim 1, further comprising anextracardiac implantable medical device, wherein the first controlmodule is configured to: establish whether the extracardiac implantablemedical device is present in the patient; and modify operating mode inresponse to the extracardiac implantable medical device being present.9. The system of claim 8, wherein the first control module is configuredto modify at least one of a therapy delivery control parameter or amonitoring control parameter in response to establishing the presence ofthe extracardiac implantable medical device.
 10. The system of claim 1,wherein the second implantable medical device is functionally absent oncondition that the second implantable medical device is implanted butincapable of operating together with the first implantable medicaldevice in the implantable medical device system.
 11. The system of claim1, wherein the second implantable medical device is functionally absenton condition that the second implantable medical device is disabled. 12.The system of claim 1, wherein the second implantable medical device isfunctionally absent on condition that the second implantable medicaldevice is incapable of therapy delivery.
 13. The system of claim 1,wherein the second implantable medical device is functionally absent oncondition that the battery of the second implantable medical device hasreached end-of-life.
 14. A method performed by an implantable medicaldevice system, comprising: establishing by a first control module of afirst implantable medical device, that is configured to be implanted ina patient, whether a second implantable medical device is functionallypresent or absent in the patient; and self-configuring the first controlmodule between a first operating mode in response to establishing thatthe second implantable medical device is functionally present and asecond operating mode in response to establishing that the secondimplantable medical device is functionally absent, wherein, according toconfiguration of the first control module, the second implantablemedical device is functionally absent on condition that a battery of thesecond implantable medical device has reached a state where the secondimplantable medical device is non-functional in the implantable medicaldevice system.
 15. The method of claim 14, further comprising: producingfirst sensed event signals by a near-field sensing channel of a sensingmodule of the first implantable medical device in response to eventsoccurring in a first heart chamber; producing second sensed eventsignals by a far-field sensing channel of the sensing module in responseto events occurring in a second heart chamber; and establishing whetherthe second implantable medical device is present in response to thesecond sensed event signals.
 16. The method of claim 15, furthercomprising: sensing pacing pulses by the far-field sensing channel thatare delivered by the second implantable medical device; producing sensedfar-field pacing pulse event signals in response to sensing the pacingpulses; and establishing that the second implantable medical device ispresent in the patient based on the second sensed event signalscomprising the sensed far-field pacing pulse event signals.
 17. Themethod of claim 14, wherein: self-configuring the first operating modeby the first control module comprises selecting a first setting of apacing pulse output parameter for controlling pacing pulses delivered bythe first implantable medical device; and self-configuring the secondoperating mode by the first control module comprises selecting a secondsetting of the pacing pulse output parameter that is used at leastperiodically for controlling pacing pulses delivered by the firstimplantable medical device, the second setting different than the firstsetting.
 18. The method of claim 17, further comprising: producing firstsensed event signals by a near-field sensing channel of a sensing moduleof the first implantable medical device; producing second sensed eventsignals by a far-field sensing channel of the sensing module of thefirst implantable medical device; and determining a need for the secondimplantable medical device in response to the second sensed eventsignals when the first control module is self-configured in the firstoperating mode.
 19. The method of claim 15, further comprising:producing first sensed event signals by a near-field sensing channel ofa sensing module of the second implantable medical device; producingsecond sensed event signals by a far-field sensing channel of thesensing module of the second implantable medical device;self-configuring a control module of the second implantable medicaldevice by enabling selectable pacing modes comprising an asynchronouspacing mode and a synchronous pacing mode, the asynchronous pacing modeselectably enabled for controlling pacing pulses to the second heartchamber based on the first sensed event signals received from thenear-field sensing channel of the second implantable medical device butnot based on the second sensed event signals received from the far-fieldsensing channel of the second implantable medical device, thesynchronous pacing mode selectably enabled for controlling pacing pulsesdelivered to the second heart chamber in response to the second sensedevent signals received from the far-field sensing channel of the secondimplantable medical device and the first sensed event signals receivedfrom the near-field sensing channel of the second implantable medicaldevice.
 20. The method of claim 14, further comprising self-configuringthe second operating mode by enabling tachyarrhythmia detection and atachyarrhythmia therapy.
 21. The method of claim 14, further comprising:establishing by the first control module whether an extracardiacimplantable medical device is present in the patient; and modifyingoperating mode of the first control module in response to theextracardiac implantable medical device being present.
 22. The method ofclaim 21, further comprising modifying at least one of a therapydelivery control parameter or a monitoring control parameter in responseto establishing the presence of the extracardiac implantable medicaldevice.
 23. A non-transitory, computer-readable storage medium storing aset of instructions that when executed by a control module of a firstimplantable medical device, that is configured to be implanted in apatient, included in an implantable medical device system cause thesystem to: establish whether a second implantable medical device isfunctionally present or absent in the patient; and self-configure thecontrol module between a first operating mode in response toestablishing that the second implantable medical device is present and asecond operating mode in response to establishing that the secondimplantable medical device is functionally absent, wherein, according toconfiguration of the control module, the second implantable medicaldevice is functionally absent on condition that a battery of the secondimplantable medical device has reached a state where the secondimplantable medical device is non-functional in the implantable medicaldevice system.